eCFR Reference Browser

---

title: "21 CFR §876.5955"

source: "https://www.ecfr.gov/current/title-21/section-876.5955"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "876"

part_subject: "GASTROENTEROLOGY-UROLOGY DEVICES"

subpart_code: "F"

subpart_subject: "Therapeutic Devices"

section_number: "876.5955"

section_subject: "Peritoneo-venous shunt."

cfr_reference: "21 CFR 876.5955"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.

(b)Classification. Class II. The special controls for this device are FDA's:

(1)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”

(2)“510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and

(3)Backflow specification and testing to prevent reflux of blood into the shunt.

§876.5955 - Peritoneo-venous shunt.